UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On November 15, 2021, Inozyme Pharma, Inc. (the “Company”) issued a press release announcing that the first patient has been dosed in the Company’s Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1 Deficiency.
Also on November 15, 2021, the Company posted an updated corporate presentation on the “Investors & News” section of the Company’s website (www.inozyme.com). The information contained in, or that can be accessed through, the Company’s website is not a part of this filing. The updated portion of the presentation regarding the Company’s clinical development strategy for INZ-701 for the treatment of ENPP1 Deficiency and ABCC6 Deficiency, including its planned late-stage studies, is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| 99.1 | Excerpt from Company Presentation, dated November 2021. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INOZYME PHARMA, INC. | ||||||
| Date: November 15, 2021 | By: | /s/ Axel Bolte | ||||
| Name: | Axel Bolte | |||||
| Title: | President and Chief Executive Officer | |||||
Exhibit 99.1
ENPP1 clinical development strategy and illustrative goals for trials in adult and children patient populations Adults FIH Cohort 3 LATE STAGE STUDIES Dose: 1.8 mg/kg; n:3 Pending regulatory discussions and approval Cohort 2 Phase 1/2 DSMB Dose Phase 1/2 Extension – 48 weeks | Remain on Drug Dose: 0.6 mg/kg; n:3 Extension Selection Cohort 1 DSMB Phase 1/2 Extension Dose: 0.2 mg/kg; n:3 Placebo controlled Expansion Cohort • Confirmed clinical and genetic diagnosis Adults, Phase 2/3 – 2:1 Tx:Pbo Eligibility Criteria • Age 18 65 years • Safety and tolerability of INZ 701 Primary Objective(s) • Establish dosing regimen for future clinical development ENDPOINT MEASUREMENT • Plasma PPi Additional Objectives • Other disease relevant biomarkers PPi Blood biochemistry Planned Doses • 0.2 mg/kg, 0.6 mg/kg, and 1.8 mg/kg; twice weekly subcutaneous Calcification High resolution radiography Phase 1 Duration • 7 weeks duration per subject; staggered recruitment per cohort (DSMB) Pain Pain Scores Children Infants – 0 2 years Pediatric – 3 18 years Infants, Phase 2/3 Open Label – 48 weeks Pending regulatory discussions and approval Pending regulatory discussions and approval ENDPOINT MEASUREMENT ENDPOINT MEASUREMENT PPi Blood biochemistry PPi Blood Calcification High resolution radiography Skeletal Abnormalities RGI C, RSS Survival Alive at 6 months Growth Rate Pediatric, Phase 2/3 Open Label – 48 weeks 23 DSMB = Data Safety Monitoring Board
ABCC6 clinical development strategy and illustrative goals for trials in adult and children patient populations Adults FIH Cohort 3 LATE STAGE STUDIES Dose: 1.8 mg/kg; n:3 Pending regulatory discussions and approval Cohort 2 Phase 1/2 DSMB Phase 1/2 Extension – 48 weeks | Remain on Drug Dose: 0.6 mg/kg; n:3 Extension selection Cohort 1 DSMB Phase 1/2 Extension Dose: 0.2 mg/kg; n:3 Dose Placebo controlled Expansion Cohort • Confirmed clinical and genetic diagnosis Adults, Phase 2/3 – 1:1 Tx:Pbo – 48 weeks Eligibility Criteria • Age 18 65 years • Safety and tolerability of INZ 701 Primary Objective(s) • Establish dosing regimen for future clinical development • ENDPOINT MEASUREMENT Plasma PPi Additional Objectives • Other disease relevant biomarkers PPi Blood biochemistry Planned Doses • 0.2 mg/kg, 0.6 mg/kg, and 1.8 mg/kg; twice weekly subcutaneous Vascular calcification progression High resolution radiography Phase 1 Duration • 7 weeks duration per subject; staggered recruitment per cohort (DSMB) Maintain or slow vision loss Children Infants – 0 2 years Pending regulatory discussions and approval ENDPOINT MEASUREMENT PPi Blood biochemistry Calcification High resolution radiography Infants, Phase 2/3 Open Label – 48 weeks Survival Alive at 6 months 25 DSMB = Data Safety Monitoring Board